Olympia Pharmacy Recalls PEN-DEX-CHLOR Injection Due to Sterility Concerns
Olympia Pharmacy is recalling PEN-DEX-CHLOR Injection because FDA inspection findings raised concerns about quality control processes and assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of sterility failure in an injectable drug.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling PEN-DEX-CHLOR Injection. The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility for the product.
The affected product is identified by the code C5108 with an expiration date of 9/10/13. The recall covers one unit of the injection. Distribution was nationwide and in Puerto Rico.
Consumers should stop using the recalled product and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- PEN-DEX-CHLOR Injection, compounded by Olympia Pharmacy, Orlando, FL
- Manufacturer
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- C5108 Exp 9/10/13
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 105 recalled by Lowlite Investments, Inc. D/B/A Olympia Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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